Enhancing Risk Management in Pharma Industries: Analysing Hazardous Events, Assessing Barrier Efficacy and Calculating Mitigated Event Frequency Through Layer of Protection Analysis (LOPA)

Abstract

Pharma manufacturing involves handling and processing various potent and hazardous chemicals that pose risks such as toxicity, flammability, and reactivity, which can lead to catastrophic events such as fire, explosion, and toxic releases. Risk Management plays a major role in ensuring the safety of the people, process and plant. This paper presents the application of Layers of Protection Analysis (LOPA) in the pharmaceutical industry to assess and mitigate process risks. Through a case study approach, various hazardous scenarios within a pharmaceutical plant are analyzed, demonstrating the effectiveness of existing control measures and identifying areas for additional risk reduction. The study particularly focuses on the management of fire and explosion risks arising from various hazardous scenarios such as inadequate intertisation, exothermicity, runaway reactions, and static charge in centrifuges. By implementing various protection layers using the LOPA methodology, the risk associated with this scenario is significantly reduced. The LOPA methodology provides a systematic framework for safety engineers to evaluate process risks, assess the reliability of existing safeguards, and determine the need for supplementary risk mitigation measures. Furthermore, it facilitates comparative risk assessments across different pharmaceutical plants, emphasizing the importance of initiating event frequency and promoting the adoption of inherent safety principles in process design.